L-carnitine and Coenzyme Q10 in Relation to the Oxidative Stress, Antioxidant Enzymes Activities, Inflammation, and the Risk of Coronary Artery Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Taichung Veterans General Hospital
ClinicalTrials.gov Identifier:
NCT01819701
First received: March 15, 2013
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

Cardiovascular disease (CVD) is the leading cause of Taiwan. L-carnitine (LC) and coenzyme Q10 is recognized as lipid soluble antioxidants. The purposes of this study are going to investigate the relation of LC and coenzyme Q10 with the markers of lipid peroxidation, antioxidant enzymes activities, and the inflammatory markers in coronary artery disease (CAD) patients. The study is designed as a three-year study. The first year is an observation study. We will recruit CAD patients who are identified by cardiac catheterization as having at least 50% stenosis of one major coronary artery, and age-gender matched healthy subjects. The concentrations of LC, coenzyme Q10, lipid peroxidation markers (TBARS and ox-LDL), antioxidant enzymes activities (catalase, glutathione peroxidase, glutathione reductase, and superoxide dismutase), and inflammatory markers are going to analysis. The second year is a single-blind, single dose intervention study. CAD subjects are recruit form the first year and randomly assigned to placebo, coenzyme Q10-150 (150 mg/d), coenzyme Q10-300 (300 mg/d), LC-1000 (1000 mg/d) or LC-2000 (2000 mg/d) groups. Intervention is going to administration for three months. Fasting blood will be obtained in each month and determine the concentration of LC, coenzyme Q10, lipid peroxidation markers, antioxidant enzymes activities, and inflammatory markers after intervention. The third year is a single-blind, multiple doses intervention study. We are going to measure the CAD subjects from the second year intervention study. After three months washout period, the subjects are assigned to placebo, coenzyme Q10-150 plus LC-1000, coenzyme Q10-150 plus LC-2000, coenzyme Q10-300 plus LC-1000, and coenzyme Q10-300 plus LC-2000 groups. Intervention is going to administration for three months. Fasting blood will be obtained in each month and determine the concentration of LC, coenzyme Q10, lipid peroxidation markers, antioxidant enzymes activities, and inflammatory markers after intervention. Hopefully, the results of this study could provide information of LC and coenzyme Q10 supplementation for clinical dietitian in advising CAD patients.


Condition Intervention Phase
Coronary Artery Disease
Dietary Supplement: LC-1000
Dietary Supplement: LC-2000
Dietary Supplement: Q10-150
Dietary Supplement: Q10-300
Other: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Taichung Veterans General Hospital:

Primary Outcome Measures:
  • Antioxidant [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Antioxidant ability measurements: lipid peroxidation markers (MDA), antioxidant enzymes activities (catalase, glutathione peroxidase, and superoxide dismutase).

  • Anti-inflammation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Measure inflammatory markers:hs-CRP, TNF-alpha, and IL-6.


Enrollment: 47
Study Start Date: January 2013
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
starch
Other: Placebo
Experimental: LC and Coenzyme Q10
L-carnitine: 1000 mg/d and 2000 mg/d Coenzyme Q10: 150 mg/d and 300 mg/d
Dietary Supplement: LC-1000
L-carnitine 1000 mg /d
Dietary Supplement: LC-2000
L-carnitine: 2000 mg/d
Dietary Supplement: Q10-150
Coenzyme Q10: 150 mg/d
Dietary Supplement: Q10-300
Coenzyme Q10: 300 mg/d

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Clinical diagnosis of coronary artery disease (CAD): CAD patients were identified as having at least 50% stenosis of one major coronary artery by cardiac catheterization or as have received percutaneous transluminal coronary angioplasty (PTCA).
  • Health subjects: Subjects did not have any illnesses and a history of gastrointestinal disorder, cardiovascular disease (showed normal electrocardiogram), hypertension, hyperlipidemia, liver and renal disease, diabetes, cancer, alcoholism or other metabolic disease and exhibited normal blood biochemical values, including fasting blood glucose < 6.11 mmol/L, blood urea nitrogen (BUN) < 7.9 mmol/L, creatinine < 123.8 umol/L, alkaline phosphates < 190 U/L, glutamic oxaloacetic transaminase (GOT) < 35 U/L and glutamic pyruvate transaminase (GPT) < 45 U/L.
  • Must be able to swallow tablets

Exclusion Criteria:

  • age < 20 years old
  • pregnancy women
  • taking antioxidant vitamins supplements
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01819701

Locations
Taiwan
Taichung Verterans General Hospital
Taichung, Taiwan, 40705
Sponsors and Collaborators
Taichung Veterans General Hospital
  More Information

No publications provided by Taichung Veterans General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Taichung Veterans General Hospital
ClinicalTrials.gov Identifier: NCT01819701     History of Changes
Other Study ID Numbers: SF11263
Study First Received: March 15, 2013
Last Updated: March 12, 2014
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Carnitine
Coenzyme Q10
Ubiquinone
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on October 21, 2014